Details for New Drug Application (NDA): 206916
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The generic ingredient in PALONOSETRON HYDROCHLORIDE is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
Summary for 206916
Tradename: | PALONOSETRON HYDROCHLORIDE |
Applicant: | Baxter Hlthcare Corp |
Ingredient: | palonosetron hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206916
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 206916
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 206916 | ANDA | Baxter Healthcare Corporation | 36000-326 | 36000-326-02 | 1 VIAL in 1 CARTON (36000-326-02) / 5 mL in 1 VIAL (36000-326-01) |
PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 206916 | ANDA | Bamboo US Bidco LCC | 83703-531 | 83703-531-02 | 1 VIAL in 1 CARTON (83703-531-02) / 5 mL in 1 VIAL (83703-531-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | ||||
Approval Date: | Nov 12, 2021 | TE: | AP | RLD: | No |
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